Diamind Solutions

Security, Privacy & Compliance Overview: Protecting Your Data, Empowering Your Trials

In clinical trials, ensuring the security and privacy of sensitive data is non-negotiable. At Diamind Solutions, we prioritize security, privacy, and regulatory compliance across every aspect of the Diamind Clinical Trials Management Solution (DCTMS). Our platform is designed to meet the highest global standards, providing organizations with the confidence that their trial data is protected and their processes are aligned with regulatory requirements.

Key Features

  • Advanced Security Measures:

    • End-to-end encryption for data in transit and at rest.
    • Multi-Factor Authentication (MFA) for secure user access.
    • Role-Based Access Control (RBAC) to ensure users only access data relevant to their roles.

  • Data Privacy Compliance:

    • Fully compliant with GDPR, HIPAA, PIPEDA, and other regional privacy laws.
    • Support for Data Region Selection to meet local data sovereignty requirements.
    • Detailed audit logs for transparent tracking of system access and activity.

  • Regulatory Alignment:

    • Validated to meet FDA 21 CFR Part 11 for electronic records and signatures.
    • Infrastructure compliant with ISO/IEC 27001 for global information security standards.
    • Aligned with Good Clinical Practice (GCP) guidelines for trial integrity.

  • Resilient Infrastructure:

    • High-availability cloud architecture with 99.9% uptime and disaster recovery protocols.
    • Secure hosting environments with redundancy and data protection.

  • Transparent Oversight:

    • Comprehensive audit trails and compliance reports for regulatory reviews.
    • Continuous monitoring to ensure ongoing adherence to security and privacy standards.

Description

We employ robust security protocols to safeguard your data against unauthorized access, breaches, and loss. These measures include:

  • Data Encryption: All data is encrypted both in transit and at rest, ensuring secure communication and storage.
  • Multi-Factor Authentication (MFA): Add an additional layer of security to user logins with SMS, email, or app-based authentication.
  • Role-Based Access Control (RBAC): Grant users access only to the data and functionalities they need, minimizing exposure to sensitive information.
  • High-Availability Infrastructure: Cloud-based architecture ensures 99.9% uptime with redundancy and disaster recovery protocols in place.

Commitment to Privacy

Our platform is built to comply with global data privacy regulations, ensuring that your organization’s data handling practices align with the law:

  • Regulatory Standards: Fully compliant with GDPR, HIPAA, PIPEDA, and other regional privacy laws.
  • Data Region Selection: Choose where your data is hosted to meet local data sovereignty requirements.
  • Audit Logs: Maintain detailed records of system access and activity to support transparency and regulatory audits.

Regulatory Compliance

DCTMS is designed to adhere to key regulatory frameworks, providing a validated and trustworthy solution for clinical trials:

  • FDA 21 CFR Part 11 Compliance: Ensure electronic records and signatures meet FDA requirements.
  • ISO/IEC 27001 Standards: Infrastructure built to meet global information security standards.
  • GCP Compliance: Aligned with Good Clinical Practice guidelines to ensure trial integrity and participant safety.

Why Choose Diamind for Security, Privacy & Compliance?

At Diamind Solutions, we understand the critical importance of data security and compliance in clinical research. Our platform combines advanced technology, validated processes, and regulatory alignment to protect your data and streamline your trials. From encryption to audit trails, every feature is designed to provide peace of mind for your organization and participants.

Your Data, Protected with Confidence
Contact us today to learn more about our Security, Privacy & Compliance capabilities and how we can support your clinical trial needs.